Senior Director, CMC Global Regulatory Affairs

Role Summary

The Senior Director, CMC Global Regulatory Affairs is responsible for leading all regulatory CMC development, registration, and compliance activities from early development through commercialization. This position reports to the Head of Global Regulatory Affairs and may be remote or based at Liquidia in Research Triangle Park, North Carolina.

Responsibilities

• Lead development of CMC and device regulatory submission strategies by working closely with colleagues and cross-functional project teams. Review content and maintain submission timelines to meet business objectives.
• Assess and communicate global CMC and device regulatory filing requirements to ensure all development activities comply with applicable regulations and guidelines.
• Work with CMC colleagues to develop Quality by Design (QbD) strategies for novel manufacturing processes. Assist in the conduct and appropriate documentation of all QbD related activities.
• Conduct risk assessments and develop mitigation strategies for global CMC and device regulatory matters.
• Lead and prepare CMC sections of regulatory submissions (NDA/MAA and supplements, IND/CTA, reports or correspondences, annual reports, IND/CTA amendments) and ensure compliance with regulations and standards of health authorities around the world.
• Prepare responses to regulatory authority information requests during the review process to support application approval and maintenance.
• Interface with regulatory agencies on all CMC and device matters and lead preparations for regulatory agency meetings. May also serve as primary contact with FDA for IND/NDA and supplements.
• Effectively communicate novel manufacturing processes and QbD activities to regulatory agencies.
• Work closely with Manufacturing and Quality colleagues and external vendors to prepare for GMP facility inspections by health authorities.
• Assess CMC-related and device changes and ensure those changes are reported in a timely manner to health authorities in accordance with regulatory requirements.
• Maintain and communicate knowledge and impact of relevant global CMC and device regulations, guidelines, and standards.
• Evaluate and communicate risk.

Qualifications

• Bachelor‚Äôs degree in chemistry, biochemistry, engineering, life sciences or related field required. Advanced degree preferred. RAC or similar certification a plus.
• For Director, minimum of 10-year CMC regulatory or related experience in the pharmaceutical industry; 12 years for Sr Director; 15 years for Executive Director.
• Demonstrated experience to define and execute CMC regulatory strategies with minimal oversight.
• Strong knowledge of drug development and life cycle management concepts and interdependencies with the overall development process.
• Small molecule experience preferred.
• Understanding of and experience with pharmaceutical QbD concepts and techniques.
• Excellent knowledge of FDA and ICH requirements and guidelines, with experience as FDA liaison; Knowledge of EU and other ROW regulations and guidelines preferred.
• Experience in authoring and filing INDs/CTAs/IMPDs and NDAs/MAAs.
• Experience in post-market and commercialization regulatory CMC activities.

Skills

• Excellent written and oral communication skills. Demonstrated ability to communicate complex issues to diverse audiences.
• Proven evaluative, analytical, and interpretative skills enabling review and synthesis of information used in regulatory planning and submissions.
• Demonstrated project management skills.
• Demonstrated ability to multi-task, set and shift priorities, and meet timelines in a fast-paced, innovative environment with minimal supervision.
• May supervise and oversee junior staff, contract service providers, external consultants, and in-house project teams will be required.
• Demonstrated ability to communicate, influence, learn and teach horizontally and vertically within a multi-disciplined, matrixed organization.
• Demonstrated aptitude for ‚Äòhands-on‚Äô troubleshooting and problem solving with an exemplary history as a ‚Äúself-starter‚Äù.
• Strong desire to work as part of many cross-functional teams consisting of technical, quality, clinical, and administrative team members.
• Unrelenting dedication to defining strategies to support business objectives and delivering high quality results.
• Occasional travel required (<10%).

Education

• Information not separately listed beyond degree requirements in Qualifications.